Unique ID issued by UMIN | UMIN000045231 |
---|---|
Receipt number | R000051670 |
Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states |
Date of disclosure of the study information | 2021/09/14 |
Last modified on | 2021/08/23 17:30:36 |
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states
Japan |
None
Not applicable | Adult |
Others
NO
The aim of this study is to evaluate the effect of Probiotic on mood states among healthy adults
Safety,Efficacy
Cerebral blood flow, Saliva Stress Index, Questionnaire
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intake of powdered probiotic for 6 weeks
Intake of powdered placebo for 6 weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
1) Subjects of both sexes aged 20 years or older and younger than 65 years.
1) Subjects with serious disorders on hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, mental and metabolic system, or related severe past medical histories
2) Subjects who are under alternative treatment (acupuncture, chiropractic and etc.) or with treatment histories of within 1 month
3) Subjects with suicide thoughts
4) Subjects who regularly take foods containing Lactic acid bacteria or Bifidobacterium such as supplements
5) Subjects who regularly intake medical drugs or supplements that affect moods or fatigue
6) Subjects with medication allergy, food allergy, or serious history of these
7) Subjects who are pregnant, under lactation or expecting to be pregnant during this study
8) Subjects who participated in other study within 1 month prior to obtaining informed consent
9) Any candidates considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.
30
1st name | Hirotaka |
Middle name | |
Last name | Nagashima |
Medical Corporation Chisei-kai Tokyo Center Clinic
Clinical Research Center
103-0028
Yaesu KT Bldg 1-1-8 Yaesu, Chuo-ku, Tokyo, Japan
03-3276-6935
nagashima_hirotaka@tc-clinic.jp
1st name | Shigeru |
Middle name | |
Last name | Imai |
Leverage Brain Inc.
Clinical Trial Department
105-0004
Shinbashi2-16-1 Minato-ku, Tokyo, Japan
080-7290-0404
imai@levbrain.com
Leverage Brain Inc.
Morinaga Milk Industry Co., Ltd.
Profit organization
Japan Conference of Clinical Research
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
03-6868-7022
jccr-info@cts-smo.com
NO
医療法人社団 知正会 東京センタークリニック(東京都)
2021 | Year | 09 | Month | 14 | Day |
Unpublished
Preinitiation
2021 | Year | 07 | Month | 05 | Day |
2021 | Year | 08 | Month | 19 | Day |
2021 | Year | 09 | Month | 15 | Day |
2021 | Year | 11 | Month | 28 | Day |
2021 | Year | 08 | Month | 23 | Day |
2021 | Year | 08 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051670
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |